Preamble

The goal of this meeting was to progress the second draft of the Discussion Paper outlining the proposed framework.

Meeting discussions

The Working Group reviewed and endorsed the meeting record from 3-4 July 2002 meeting with minor amendments.

It was reiterated that the role of the Working Group was to advise the TGA, not to develop the final IVD regulatory model per se. The groups purpose was to contribute to the development of a best practice model for IVD regulation, which would then be endorsed or amended by the Australian Health Minister's Advisory Committee (AHMAC), the Australian Health Minister's Conference (AHMC) and eventually the Government. Members agreed that with respect to the Discussion Paper therefore, it's aim was to ensure that the final document provides options to cover all views.

Members considered the second draft of the IVD Discussion Paper in great detail and text in various sections of the document was clarified and amended. In particular, there were detailed discussions on the sections on the rules for the classification of IVDs used in screening and diagnostic testing, in-house tests and home use IVDs for use in the detection of serious disease markers.

There was discussion about the length of the comment period for the document once it had been issued to stakeholders, and it was agreed that six (6) weeks was a suitable length of time. It was also noted that the TGA would make arrangements to host open consultation sessions in most capital cities during the comment period.

There was discussion about next steps after the comment period, and whether members would have an opportunity to see the comments received. It was agreed that a further meeting would be organised once the consultation period had closed.

Key outcomes

Outcomes of the meeting included:

• clarification and revision of the text in numerous sections of the draft discussion paper;
• agreement that the revised discussion paper would be circulated to the Working Group for additional comments prior to publication;
• agreement that the comment period for the Discussion Paper should be 6 weeks; and
• consensus was not reached on the proposed regulation of in-house IVDs.

Next meeting

It was agreed that the Working Group would reconvene to discuss the submissions received.

Rita Maclachlan
Chair
July 2003